PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of August 19, 2025 No. UP-137

About additional measures for regulation of drug circulation and medical products

For the purpose of providing the population with high-quality, safe medicines and medical products with the guaranteed efficiency, enhancement of processes of regulation of their address, creating favorable conditions for subjects of entrepreneurship, and also acceleration of processes of integration into the World Trade Organization I decide:

I. Purposes

1. Determine main objectives of regulation of drug circulation and medical products:

(a) providing the population with the high-quality, safe and effective medicines and medical products recognized by the World Health Organization and registered in the countries which system of regulation has the high level of maturity;

(b) reduction of order of registration of medicines and medical products in compliance with the international requirements;

(c) regulation of the address in the pharmaceutical market of the Republic of Uzbekistan of the medicines and medical products made on the basis of international standards of quality.

II. Enhancement of order of registration by recognition

2. Establish procedure according to which since October 1, 2025 the medicines registered by the following foreign organizations are subject to state registration in the Republic of Uzbekistan by their recognition:

(a) the regulatory bodies included before entry into force of this Decree in the list of the World Health Organization (WHO Listed Authorities);

(b) the regulatory bodies having 4 level of maturity (Maturity Level 4) on the Global tool of comparative assessment (Global Benchmarking Tool) of the World Health Organization.

III. Enhancement of regulation of drug circulation and medical products

3. Perform since January 1, 2026 the product circulation of medical appointment and medical equipment in the following procedure:

(a) to carry out state registration of products of medical appointment and medical equipment as medical products;

(b) to classify medical products by four levels of safety taking into account high risks probability, connected with human life;

(c) to carry out state registration of medical products on the basis of the differentiated requirements taking into account high risks probability for human life;

(d) to carry out state registration of medical products based on positive results of clinical trials (except for the medical products carried to class with low risks probability for human life, which are subject to registration by recognition or the list of which affirms the Ministry of Health).

4. Determine that since January 1, 2026:

(a) from domestic and foreign manufacturers state registration of medicines and prolongation of effective period of the registration certificate requires receipt of the national certificate "Proper production practice - GMP" (except for the medicines which passed prekvalifikation of the World Health Organization and being subject to state registration by recognition);

(b) by results of state registration of medicines and medical products the registration certificate with effective period is issued five years to domestic and foreign manufacturers. At the same time effective period of the registration certificates which are earlier issued to domestic manufacturers on termless basis is established to equal five years, since the date of entry into force of this Decree;

(c) production of medicines and medical products can be performed based on the order of their owner under the agreement (including transfer of technologies) by the producers having the corresponding license. At the same time the registration certificate on medicines and medical products is drawn up addressed to the owner or the company which is directly performing their production;

(d) the licensed requirement for implementation of activities for retail sale of medical products is cancelled, these activities are performed by the notification of authorized body.

5. Establish procedure according to which in case of execution of the certificate of conformity for medicines and medical products are required:

(a) for medicines - since January 1, 2027 the national certificate "Proper production practice - GMP" by sight medicines of the producer;

(b) for medical products - since July 1, 2027 the certificate of conformity of the producer to the national ISO:13485 standard.

6. Determine that in case of execution of the certificate of conformity for medicines and medical products the certificate of conformity to the national standards "Proper Production Practice — GMP" and "ISO: 13485" it is not required for:

(a) the orphan medicines and medical products applied to diagnostics and treatment of the orphan diseases imported by request of the Ministry of Health without state registration, and also the medicines and medical products applied to prevention of especially dangerous infections and infections posing epidemiological threat, their diagnostics and treatment;

(b) medical products on which obligatory execution of the certificate of conformity is not required;

(c) medicines and the medical products which are subject to state registration by their recognition;

(d) medicines and the medical products which passed prekvalifikation (prequalification) of the World Health Organization.

IV. Organization, providing and control of execution of the Decree

7. Approve the Plan of measures for regulation of drug circulation and medical products according to appendix No. 1.

8. To the Ministry of Health in two-month time:

(a) together with the interested ministries and departments to make in the Cabinet of Ministers offers on the changes and amendments in acts of the legislation following from this Decree;

(b) to introduce to the Cabinet of Ministers the bill on modification and amendments in the Law of the Republic of Uzbekistan "About medicines and pharmaceutical activities".

9. To the Uzbek technical regulation agency in coordination with the Ministry of Health in two-month time to approve the national standard of the Republic of Uzbekistan harmonized with the international standard "ISO: 13485".

10. Make changes to some acts of the President of the Republic of Uzbekistan according to appendix No. 2.

11. Assign to the Minister of Health A. A. Hudayarov the personal responsibility for the effective organization of execution of this Decree.

Implementation of coordination and control of activities of the departments responsible for execution of this Decree to assign to the Prime Minister of the Republic of Uzbekistan A. N. Aripov.

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